You are an emerging biopharma outsourcing to a trusted CDMO that has selected its location wisely – an important factor in your selecting it. Now you’ve determined to establish some of your own development or manufacturing facilities. Would it be beneficial to build close to your CDMO?
- CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward
- How To Build An Exceptional Medical Device Biocompatibility Program
- “Relational Contract” Supports Outsourcing Of Hepatitis B Immunotherapy
- 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
- 6 Key Steps For Cell Therapy Clinical Development Success
- Surprise! CEOs Select CDMOs
- Biotech Patenting: 4 Tips & Personal Experiences
How To Build An Exceptional Medical Device Biocompatibility Program
In recent years, biocompatibility and compliance with the ISO 10993 family of standards have been an area of significant attention. Demonstrating biocompatibility is an integral part of any device development. This article explains how to integrate a biocompatibility toxicologist into your team and his/her role within the development process.
5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.
6 Key Steps For Cell Therapy Clinical Development Success
While the simplest option for a small or emerging biotech is to outsource protocol and clinical development to a consultant or CRO, a disengaged or absent sponsor is unlikely to have its objectives realized. Prior to engaging with a consultant or CRO, you can take these six steps that are likely to leave both parties engaged in the clinical development process.
Biotech Patenting: 4 Tips & Personal Experiences
When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.
EU MDR Postmarket Clinical Follow-Up Compliance: 3 Tips & 3 Pitfalls
The EU MDR regulation imposes new requirements for clinical evaluation for some Class III and implantable devices, narrowing equivalence routes and placing greater emphasis on postmarket clinical follow-up (PMCF). This article provides three best practices for compliance and then offers an overview of common issues observed in notified body submissions.
FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History
On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. The final rule provides clarity to manufacturers, but many stakeholders are still unsatisfied with the evidentiary standard for determining intended use, perhaps forecasting legal challenges to the regulation.
Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing
Deviations in the pharmaceutical process generally lead to non-compliance and issues meeting demand, so they require careful tracking, monitoring, and remediation. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.
How To Find & Manage Biotech Consultants Effectively
The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.
PHARMA OUTSOURCING WHITE PAPERS
Factoring The “What Ifs” Into Supply Forecasting
Growing urgency in the biopharmaceutical industry to speed new products to market leads to greater appreciation for supply forecasting as a strategic and highly complex success factor. Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.
Embedding Your Drug Strategy Within A Solid Foundation For Success
This white paper looks at the set of trends inﬂuencing pharmaceutical development and manufacturing strategy today, and how these drivers are inﬂuencing new business models with outsourced partners.
Principles Of Raman Spectroscopy And Application To Pharmaceutical Development
Discover how Raman spectroscopy is used to analyze a chemical compound’s structure and an example of how this technique is used to analyze amorphous material created through a hot melt extrusion process.
Getting Your Investigational Drug Regulatory Ready
Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.
Identifying Enhanced Needle Solutions And Integrated System Solutions To Serve The Chronic Disease Market
Needle innovations, including shorter needles with ultra-thin wall technology for prefilled syringes, support the delivery of drugs with greater volumes and viscosities, enhancing end-user experience.
Six Principles For Getting Pharma Development Right From The Start
This paper highlights six keys that pharma and biotech companies should keep in mind when selecting a partner to synthesize an API to ensure the development process tracks toward success.
COVID-19 AND YOUR SUPPLY CHAINS
The Latest Analysis And Advice From Outsourced Pharma
OUTSOURCED PHARMA CONTENT COLLECTIONS
In this collection of recent editorials, Outsourced Pharma Chief Editor Louis Garguilo wades into the noisy intersection of national and international politics, and our pharmaceutical industry, from the perspective of our main focus on drug development and manufacturing outsourcing.More Content Collections
PRODUCTS & SERVICES
SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.